Quote:

---

Although, assuming the M/M results are good, I imagine they have the most value, and offer the most leverage, if they are released PRIOR to the DSMC's look at the S/C.

---

I'd agree that M/M data should be released as soon as it's available for greatest effect but I feel the DSMC process is the lynch pin in receiving EUA any time soon.

I'd think the DSMC would already have some efficacy number in mind (two‐sided P‐value <0.001 in favor?) that warrants recommending termination of the trial due to overwhelming benefit.

Based on the explanation below, even if this recommendation is granted, I believe a separate request for emergency approval still must be submitted to the FDA which, of course, could be still denied though I'm not sure how often that scenario occurs.

https://en.wikipedia.org/wiki/Data_monitoring...ng_benefit
(I know is only wikipedia, but still...)